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![USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines](https://static.wixstatic.com/media/nsplsh_5a3366585075786131356b~mv2_d_4032_3024_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_5a3366585075786131356b~mv2_d_4032_3024_s_4_2.jpg)
Sharan Murugan
- Oct 6, 2022
- 1 min
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...
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![USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA](https://static.wixstatic.com/media/nsplsh_4e626a6a63616f796d496f~mv2_d_2944_4132_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_4e626a6a63616f796d496f~mv2_d_2944_4132_s_4_2.jpg)
Sharan Murugan
- Oct 3, 2022
- 1 min
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
Earlier today (03 October 2022) USFDA released two finalized guidelines "Review of Drug Master Files in Advance of Certain ANDA...
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![USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules](https://static.wixstatic.com/media/nsplsh_3f0e435135364e97bcaaec45acd21acb~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_3f0e435135364e97bcaaec45acd21acb~mv2.jpg)
Sharan Murugan
- Oct 3, 2022
- 1 min
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance "...
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![USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests](https://static.wixstatic.com/media/nsplsh_9645111ec3c1444b9883137b502b7ea8~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_9645111ec3c1444b9883137b502b7ea8~mv2.jpg)
Sharan Murugan
- Sep 30, 2022
- 1 min
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...
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![USFDA Guidance: Clinical Investigations of Medical Products Involving Children](https://static.wixstatic.com/media/nsplsh_54446f506555534f443163~mv2_d_12032_8032_s_5_3_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_54446f506555534f443163~mv2_d_12032_8032_s_5_3_2.jpg)
Sharan Murugan
- Sep 25, 2022
- 1 min
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...
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